Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy

Infection During Renal Replacement Therapy Clinical Trial

Official title:

Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02007122
• Other study ID #: CEFTAROLINE_RRT
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: March 2023

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: Florian Thalhammer, Prof. MD
• Phone: 0043 1 40400
• Email: florian.thalhammer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years, able to give written informed consent

• Suspected or proven bacterial infection requiring parenteral antibiotic therapy.

• Renal replacement therapy (continuous or intermittent)

Exclusion Criteria:

• Known hypersensitivity to ceftaroline or other cephalosporins, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.

• An expected survival of less than two days.

• Known pregnancy

• Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study

• Ceftaroline as monotherapy for resistent species or fungal infections.

• Other reasons oposing the study participation on the discretion of the investigators

Related Conditions & MeSH terms

• Infection During Renal Replacement Therapy

Intervention

Other:
• Ceftaroline in CRRT
Plasma levels of ceftaroline will be measured in patients receiving CRRT
• Ceftaroline in IRRT
Ceftaroline plasma levels will be measured in patients receiving intermittent renal replacement therapy

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels.	Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.	day 15